Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes

NCT ID: NCT07134049

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to investigate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments following Congenital Brachial Plexus Injury (CBPI), and to support the overall developmental processes of affected children.

Detailed Description

Detailed Description:

Congenital Brachial Plexus Injury (CBPI) is a peripheral nerve injury occurring during childbirth that can lead to varying degrees of sensory, motor, and functional impairments. These impairments may adversely affect not only motor skills but also sensory processing and cognitive development, particularly in early childhood when neurodevelopment is highly plastic. Sensory integration therapy is a child-centered, play-based intervention designed to improve the brain's ability to process and integrate sensory information from the tactile, vestibular, proprioceptive, visual, and auditory systems. By providing enriched and graded sensory experiences, this therapeutic approach aims to promote adaptive responses, improve motor planning, enhance self-regulation, and support overall developmental progress.

The purpose of this study is to evaluate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments in children with CBPI aged 7 to 35 months. Participants in the intervention group will receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy programs. Developmental outcomes will be assessed using standardized assessment tools before and after the intervention. The findings of this study are expected to contribute to evidence-based rehabilitation approaches for children with CBPI and to inform early intervention strategies aimed at optimizing sensory, motor, and cognitive development.

Conditions

Obstetric Brachial Plexus Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

Participants in this group receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy program. Each session lasts approximately 45 minutes and is based on the core principles of sensory integration therapy. The intervention includes activities involving tactile, vestibular, proprioceptive, auditory, and visual stimuli, tailored to each child's sensory processing needs. Therapy is provided in a sensory-enriched and safe environment, and aims to promote adaptive responses, motor planning, self-regulation, and functional skills. Sessions are play-based and structured to support engagement and motivation.

Group Type: EXPERIMENTAL

sensory integration therapy

Intervention Type: OTHER

Sensory Integration Therapy (SIT) is a client-centered rehabilitation approach aimed at improving adaptive and functional responses to sensory stimuli in changing environments. It is based on structured, individualized activities conducted in enriched sensory environments. These environments are designed to be engaging and motivating for children through the use of interactive and playful tasks that match their sensory processing profiles.

Sensory integration plays a key role in motor planning, postural control, attention, and emotional regulation. Deficits in sensory integration-particularly in vestibular, tactile, and proprioceptive systems-may result in poor muscle tone, difficulty with balance and coordination, and impaired motor planning. These issues can negatively impact the development of gross motor, fine motor, language, and academic skills. For this reason, sensory-based interventions that support neural organization and promote adaptive responses are commonly recommended i

control group

Participants in this group will not receive any sensory integration therapy during the 8-week study period. Instead, they will continue with their existing routine physiotherapy program, which may include general motor exercises, range of motion activities, and other standard therapeutic practices. No additional sensory-based interventions will be introduced. This group serves as a comparator to assess the effects of sensory integration therapy provided to the experimental group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sensory integration therapy

Sensory Integration Therapy (SIT) is a client-centered rehabilitation approach aimed at improving adaptive and functional responses to sensory stimuli in changing environments. It is based on structured, individualized activities conducted in enriched sensory environments. These environments are designed to be engaging and motivating for children through the use of interactive and playful tasks that match their sensory processing profiles.

Sensory integration plays a key role in motor planning, postural control, attention, and emotional regulation. Deficits in sensory integration-particularly in vestibular, tactile, and proprioceptive systems-may result in poor muscle tone, difficulty with balance and coordination, and impaired motor planning. These issues can negatively impact the development of gross motor, fine motor, language, and academic skills. For this reason, sensory-based interventions that support neural organization and promote adaptive responses are commonly recommended i

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Confirmed diagnosis of obstetric brachial plexus injury (OBPI) Age between 7 and 35 months No additional diagnosed neurological, psychiatric, and/or muscular disorders No diagnosed mental retardation or cognitive disorder that would prevent participation in assessments Written informed consent from parents or legal guardians

Exclusion Criteria

Severe visual or hearing impairment preventing participation in assessments Participation in another experimental rehabilitation program within the last 3 months

• Minimum Eligible Age: 7 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Elif Cimilli

MSc, Principal Investigator, Occupational Therapist (MSc)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Çiğdem Öksüz, PhD, Professor,

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University Faculty of Health Sciences, Department of Occupational Therapy

Locations

Hacettepe Univeristy

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

elif cimilli, MSc

Role: CONTACT

e.ciminli19@gmail.com

+905469598168

Facility Contacts

cigdem oksuz, Professor

Role: primary

+90 533 344 22 85

Other Identifiers

Hacettepe University

Identifier Type: OTHER

Identifier Source: secondary_id

E-68552689-000-00004173157

Identifier Type: -

Identifier Source: org_study_id